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Title 21 → Chapter I → Subchapter H → Part 864 → Subpart F → §864.5620 |
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices
§864.5620 Automated hemoglobin system.
(a) Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.
(b) Classification. Class II (performance standards).
[45 FR 60601, Sept. 12, 1980]